Orthosis for scar tissue treatment

ABSTRACT

The invention concerns an orthosis ( 1 ) for preventing and treating hypertrophy ( 22 ), keloid, bridle, scar retraction, to improve functional and aesthetic quality and enable scar growth. Said orthosis ( 2 ) enables to enhance [sic] the quality of healing, to decrease the number of repair surgical procedures for functional purposes. It provides the patient with more aesthetic movements. Said orthosis is characterized in that it comprises one or more treatment units ( 2 ) having a mechanical pressing action ( 13 ) on the scar and an activator ( 3 ) for enhancing the action of the units ( 2 ), for increasing their attachment, for transmitting traction derived from the patient&#39;s movements.

The present invention is designed to treat, in a preventive or curativeway, hypertrophy, retraction, fibrosis, etc. that are secondary to deeplesions of the skin and soft tissues.

We see in patent EP824 016 that pressure exerted by pressure bands hasbeen shown to be insufficient, whereas rigid strips manufactured of hardplastic material, according to proper accepted practice, prevent healingof the skin. To overcome these drawbacks, the present invention providesa device that treats scar tissues, and comprises a covering device, madeof a soft compatible polymer, which comes into contact with the scartissue, and a support element made of rigid material. An inflatabledevice, placed between the soft covering device, and the rigid supportelement, presses the soft-material covering device onto the scar tissueswith optimal pressure, which makes wearing the device comfortable over along period of scarring process. The device is applied in particular toa patient's face, so as to distribute pressure between bony projectingareas and recessed areas, in order to make wearing this device morebearable for the patient. Moreover, this mask can be heavy and complex;both in its construction and its adjustment as well as its upkeep. Sucha device is difficult to disinfect and is the source of numerousinfections.

In order to overcome these drawbacks and encourage proper and rapiddermal scarring, the invention offers a selective means of pressuretherapy, and is innovative because it is distinguished by these factsknown today by the specificity of its actions. It can be easilyrecognized by the appearance of its compressive surface. This surfaceconsists of grooves that are inconsistent in their depth and width; theyare indicated by lines that vary in curve, size, and arrangement whichdelineate enclosed spaces that are not necessarily joined or closed.These sinuosities in the compression area face the scarred area beingtreated, or are on the edge of the healthy skin area. This orthosisexerts selective prolonged pressure and allows its components to becontrolled.

It is especially useful for the treatment of scars from deep burns,starting on the fifteenth day of neo-epidermization or transplant duringthe neodermal scarring phase. It allows dermal scarring to becontrolled. Among other things, scarring complications are aggravated bymovements and growth. This treatment improves a good number of scars orsubcutaneous lesions of varying etiologies such as: surgical incisions,dermabrasions, tumor excisions or cutaneous malformations,post-laser-therapy scarring, stretch marks, wrinkles, tendinitis,Dupuytren's contraction, or any other condition which might result in asignificant alteration of the base membrane, the dermis and the softtissues. It acts on scars in many different ways, which are modulatableby area. It specifically treats each scarring abnormality, notablyanchorages or areas of adherence for slip planes, adhesions, andfibroses and re-coordinates them. Each scarring complication,localization, and shape has a corresponding groove arrangement. Thewealth of these grooves translates the complexity of its action, incontrast to standard means of therapy. It creates local limitedpressures, well-tolerated doses that are reproducible and capable oftargeting selected lesions between scars. It administers pressure suchthat, when cicatricial blanching exists opposite the groove bases, whichtranslates into an effective neovascular compression, which causesischemia but not necrosis. It causes hyperpressure points on the scar.Average pressure at groove contact is greater than that created withstandard pressure therapy techniques: pressure garments, transparentrigid compresses, including those that are pneumo-hydraulic due to theiroverall homogeneous action, which is related to their significant andsmooth support surface. Its action allows discriminating compressiondepending on the location, and a modulated neocapillary pressureregulation by area, which refines the possibilities for controlledischemia. Moreover, it takes into consideration the functional stressesthat are specific to the treated area. Overall, it coordinates thetensions between scars and optimizes the scars' mechanical properties.The orthosis offers the advantage of being extra-corporeal, non-invasivefor the patient, without other means of action except for the pressurebeing exerted. It acts favorably on points of flexion.

Often life threatening in the past, burns in a child can today stilllead to functional and aesthetic difficulties, with many months ofrestrictive treatment involved as well. Interest in orthosis goes beyondthe acute inflammation phase. The after-effects remain significant andgrowth is the dominant aggravating factor during this time, whichcorresponds to an absence or near-absence of therapeutic techniques.Negligence leads to cicatricial fibrosis and limitation of slip planes,functional limitations and aesthetic damage that can be significant.

Through its prolonged mechanical action, the invention offers the use ofthe patient's natural potential to assist in healing. It reduces theinitial phase and improves functional and esthetic results. It optimizesscar growth. This invention makes surfaces with significant areas ofinjury more accessible to treatment, and their progress during growth inyoung patients.

Initial surgical results, like reparative surgery, depends to a largeextent on the neoderma, and in particular the existence of anchorages.Orthosis according to the invention allows the patient to optimize hiscicatricial status, to meet functional needs and to access reparativesurgery for esthetic purposes.

FIG. 1 shows a scar and a cross-section view of the scarring orthosis(1) centered on a therapeutic unit (2). It shows that all directpressure (18) on the cupola (5) increases divergent centrifugal pressure(15) and vertical penetration (16) into groove (6). This causes it toact beyond the scar contact surface.

FIG. 2 shows a view from above of the orthosis, centered on unit (2).Activator (3) generally encloses a member segment and is fastened downby means of an adhesive (10). We can see that all traction on the grooveedges (17) causes divergent centrifugal inter-cicatricial tensions (19)around the edge of the unit.

FIG. 3 is a cross-sectional view of the orthosis and the scar, showingactivator (3) and its traction action (17) on unit (2). Divergentpressure forces are increased (15) and penetration forces (16) aremaintained or increased. The model shows that there are pressurescorresponding to the inter-cicatricial tensions (19).

FIG. 4 shows an orthosis composed of an open system where multiplesub-units act together (4) to reproduce the base unit action (2) of theclosed system according to the principles of the invention. This isuseful for the treatment of large scars.

FIG. 5 shows a metacarpal cross-section cut. This hand is equipped witha postural splint (30) that serves as a counter-support and immobilizerin the case of an extended bum of the palm. Plate (9) in this example ismodeled in units. It is fastened to the splint edges (30). Activator (3)exerts a pressure (18) on cupolas (5); here through the small nipples(31) whose hardness and size allow the action to be modulated. Thisorthosis-splint association allows concave areas to be treated.

FIG. 6 illustrates the current pressure therapy treatment model that iscommon to: compressive garments (36), sponges (37), silicones, rigidpneumatic compressions. Compression indication relies on overall testingcriteria, which essentially take the scar contours into consideration aswell as the scar structure or localization. The overall hypertrophicscar is compressed without modulatable inter-cicatricial pressuredifferential, divergent action or consideration of area; anchorage (23),hypertrophy (22) . . . .

FIG. 7 shows a back view of a child fitted with an original kyphosiscorrection device with its thermoformable plastic interscapularhemivalve, molded in the corrected position, and its stuffed underarmcuffs pulling the shoulders.

FIG. 8 shows the profile and the front hemivalve under the ribcagevents. The two valves are jointed so that they move along with breathingmotions. Expansion in the vertical axis of the thoracic cage isfacilitated at the expense of the anteroposterior. The kyphosiscondition is corrected with each inhalation.

FIG. 9 shows the orthosis (1). We note the corrective stuffed armpitcuffs and the anterior valve that covers the last two rib arches andmolds a hollow in the top of the abdomen and specifically in the riblouvers. The patient is thus immobilized in the correct correctiveposition for his kyphoscoliosos, and the orthosis (1) acts effectivelyon the thoracic scar.

FIG. 10 shows the peri-mammary cutout and the necessary adaptations inadolescents, with attachment of the orthosis onto the correctiveelements.

Treatment of breast scarification requires adaptive brassieres andaddition of specially shaped units (2).

FIG. 11 shows the original different cutout of the posterior valvenecessary for an adolescent relating to correction for confirmedkyphoscoliosis. The posterior valve creates supports opposite it: in themiddle and at the top of the kyphosis, laterally to the sub-acromialregions and those below the pelvic hemi-basin.

FIG. 12 is the profile view. The posterior and anterior iliac spines arecovered. Orthosis (1) is positioned in a manner similar to that in FIGS.(9) and (10).

FIG. 13 shows a cross-section view of the scarring orthosis (1) centeredon a therapeutic unit (2).

The scarring orthosis (1) features projections that exert differentialpressures on the scar (15, 16) so as to control hypertrophy (22),anchorages (23), retractions and fibrosis. Orthosis (1) is distributedin treatment units (2) that are isolated or associated; this system canbe closed or open. Reliefs are produced in a plate, preferably ofelastic material (9). The reliefs constitute grooves (6) whose curve anddepth regulate pressure so as to act on certain hypertrophic or keloidalscar projections as well as on deep lesions in the cicatricial derma.The transverse radius of the curvature of the groove (6), designed forcontact is between 0.1 and 15 mm. Cupola (5) surpasses the plane of theplate, on one side of the groove, and it increases its elasticity in itsdeep plane and modulates pressures exerted there. An external force onits top reinforces this action. Elementary plate (9) is comprised ofseveral associated layers or juxtapositions: plastics, foams, gels,silicones or any other material that confers a gradient of shorehardness and elastic powers on it that differ locally.

The current therapeutic module scrupulously administers homogeneouspressure over the entire hypertrophic surface without which theuncompressed hypertrophic areas would escape and would not developproperly. The goal is to obtain a smooth scarring on this unaestheticcurve, which is awkward and painful when pinched. A pneumatic orhydraulic system can be a contributing means for the production of anorthosis but it is neither indispensable or sufficient, because its roleis that of an adjunct and it does not in any case represent the keycomponent of the invention. It can be associated either as an activatoron standard units, or connected to tubular grooves. Mechanizing thedevice allows it to massage the wearer. In all cases, specificity of thecontact surface and its grooves must be present. Information provided inpatent EP824 016 (LEUVEN K U RES § DEV; BOCK ORTHOPED IND (DE))discourages the use of pressure due to the fact that “they impedehealing” and reports a variation based on current therapeutic models,whereas the orthosis in this invention rests on the application of aninnovative therapeutic model. The shape of grooves (6) transversallyfollows a determined curve according to the areas and depth of the scarbeing treated. Plate (9) is divided into several units comprising one ormore grooves (6), thus creating a shape that may or may not be closed(FIG. 4). At least two grooves are in contact with the skin so as tohave sufficient elastic ability to store the energy necessary to exertsufficient pressure. They are modeled in a plate (9) in the same way asthe element marketed under the name ERCOFLEX®. Activator (3) allows theorthosis (1) to be fastened onto the patient and, according to the needspresented by the scar, is comprised of elements or means intended toincrease the local pressure on the deep groove areas. It is comprised ofa cuff C that is affixed to the edges the grooves, exerting a tractionforce on both sides (FIG. 3). Activator (3) and units (2) may be made ofseveral different materials or just one. Over all or part of theirsupport surface, these grooves may be smooth or may feature designs.

The scarring orthosis (FIG. 1) according to the invention is capable ofrestoring pressures so that they are targeted, oriented, anddistributed, modulating its action on the areas between scars, anddelineated by the abnormalities of the scar: anchorage, retraction,adhesion, hypertrophy, fibrosis by distributing the inter-scar tensions.It corrects parietal tension imbalance and contributes to the intrinsicrestructuring of the scar. It features areas of high pressure (11) inthe neighborhood of the low-pressure areas (12). Other than its elasticproperties, it must necessarily comprise this pressure gradient.Voluntary or automatic movements during sleep, which deliver additionalenergy (17), activate the units and make the device more effective (FIG.3). In case of total immobilization, there is less action but it is veryuseful for recently burned skin.

This orthosis (1) acts on all dermal and infra-dermal components: nerveendings, vascularization, inflammation, fibroblasts, myofibroblasts,extra cellular matrix. In a surprising manner that is not obvious, theaction of orthosis (1) is rapid; for example, after 6 weeks it gives itsearliest clinical results, which are not definitive but which permitsome improvement to be anticipated.

Its pressure action associated with the back's original describedstraightness allows it to act on associated phenomena such ascontractions or retractions encountered in kyphoscoliosis patients.

The scarring orthosis (1) is a device comprised of a plate (9) or planeof reference (FIG. 1); parts in positive upper relief or cupola (5),ensuring elasticity, and suppression of negative hollow or groovedreliefs (6) in contact with the scar. For a single unit (2), theorthosis is composed at least of two types of reliefs relative to thesurface in contact with the skin, one negative, or grooved, side (6)encircling it, and the other positive tumescence or the cupola (5): withhollows and bumps. The groove is at least on both sides of the cupola;and preferably curled. Some grooves have a wavy surface on the bottom.The cupola (5) must be equal to or taller than the plastic referencesurface (9) (FIG. 1). The form delineated by the groove (6) isadvantageously in the shape of a ring and also kidney-bean shaped, orother closed shapes, which may or may not be a function of the resultantinter-scar tension that we wish to produce, and the lesion beingtreated. The depth of the furrows, the size and shape of the unit allowus to vary the therapeutic plane more specifically: from the dermalplane to the deeper planes. Each unit (2) creates an immobilizationrelative to the scar inside the surface delineated by the grooves, andhas a specific action that can be doubled with a combined action if theyare coupled.

The scarring orthosis comprises a plate (9) and/or an activator. It iscomposed of one or more materials of different shore hardnesses: deviceswith elastic results that are capable of storing and releasing energy.Handling units (2) are reliefs that can amplify this mechanism, whiletargeting and directing its action. Activators (3) and fixating cuffsprecisely position the unit or units adapted for diagnosed scarringabnormalities (22, 23) and transmit or amplify an increase in pressurerelated to pressurizing during positioning of the orthosis or to patientmovement (FIG. 3) which becomes partially therapeutic.

Activator (3) starts outside the units scar pressure delta area (FIG. 2)or sub units (4) which comprise the orthosis (FIG. 4). The scar orthosis(1) comprises at least one unit (2), but may consist of several,juxtaposed or interactive, of greatly varying sizes (FIG. 4, 9, 10).Unit (2) is an open system if it is made with dash-shaped grooves orperipheral sub-units (4). In the case of an open system (FIG. 4), unit(2) is composed of peripheral units that are equivalent to the grooves(6); the “cupola” (5) corresponds to the area located between them. Thisis a closed system if a single groove comprises the unit.

It is possible to make incomplete models that are less active, becausethey do not fulfill all the conditions described above. Units (2) canthus comprise prefabricated reliefs, which may or may not bemodulatable, by crushing or injection into a recessed material; stampedwedges or cut into curls. They (2) are also riveted, screwed, fitted,and welded differently and separately to the activator. A pneumatic andhydraulic variant, which may be mechanized and intended to provide amassaging action, would be effective only if it meets the criteria ofthe invention and, more specifically, possess a contact surface that isactive with the adapted grooves. The complete custom model is the mosteffective.

The interface separates the skin from the unit (2). It is reduced to asimple surface treatment of the unit component or components (2) orindividualized into: silk, metalline®, cotton netting or any othermaterial.

According to a preferred and original manner of embodiment, the orthosismay be made by fashioning it of a single material. Activator (3) andunits are worked starting with a flexible plate (9) and adhesive. One ofthe products appropriate for making the orthosis is marketed under thename of Ercoflex® 2, 3, or 4 mm thick. First of all, a silhouette curveis made on the plate. The first cutouts take freedom of movement intoconsideration; if necessary, material required for fixation cuffs isreserved, which will be the starting point of the unit's edges. Thecuffs are capable of positioning and transmitting energy to the groovesand cupolas. Most often, they tighten the body perpendicular to the axisof the limbs. Unit position and curves are noted, traced on the scar.The print of the unit is taken using silicone molding or any othermaterial, and takes the curve of the body and creates the groovecounter-type. A cylinder is created that is arranged on the contour ofthe unit drawn by the practitioner onto the patient. Once coldpolymerization has taken place, this print is transferred onto theflexible thermo-formable plastic. This is mirror-image modeling,counter-type, type, negative, positive which allows the orthotic to becreated. If a memory (“smart”) material is being used, it is created, asoften as possible, using controlled cooling in an aqueous medium, inorder to conserve both elastic and mechanical properties as well ascurves. At the end of this maneuver, the device is checked against thescar and a predominant support is noted on the areas corresponding tothe grooves. Now the activator must be created using an adhesive tapeaffixed by a rivet, sewn or welded to the external edge of the groove.This creates the cuff that encloses the limb. The path of the cuffsduring movements allows the action of the orthosis can be modulated.

The shapes of the orthosis, by unit or by activator, vary according tothe application. So for example, the units, alone or together, treatareas of anchorage in the extremities of the adhesions. The body of theadhesion requires perpendicular stresses on the small areas. The scarplaque is encircled or, more often, split apart.

The activator carries out more than a simple cuff fastening. It can beflexible or rigid, inextensible or elastic, for example, a Velcro®(trademark) adhesive strip, or any other material that meets the needsof the area being treated. Its design is often complex and delicate(FIG. 7 to 12).

Simply stated, we have recourse to a compressive garment, custom,available retail or otherwise, of specific elasticity to allowadditional overall pressure and contribute to the fastening of theorthosis.

A variation of the orthosis is in the form of an insulated flexible maskor in addition under a rigid activator mask. A flexible mask is modeledon a positive, then a rigid mask underneath. On the flexible mask, unitsare designed. The flexible mask worn under the rigid mask is the mosteffective, since it acts both on points of external pressure and on topsof cupolas. The masks may be worn together or separately, which allowscutaneous constraints to be varied. Separate units can also bepermanently affixed or can be removable from the inside of the rigidmask.

The orthosis (1) associated with a hand immobilizing splint (FIG. 5)which has an activating device comprised of a rigid counter support andan elastic component; for example, a thermo-formable cap associated withmaterials of a low shore index like small cylinders cut out ofPLASTAZOTE® which exerts pressure on the tops of the cupolas. In thisorthosis, the rigid counter support forms a rigid activator mask RM andthe elastic component forms a flexible mask FM. The hardness and size ofthe cylinders or nipples modulate the support. This device allowsconcavities to be treated. It can be in the form of a simple metacarpalbracelet for a burn of moderate complexity on the palm; units andactivators are worked into a single plate.

Here the orthosis (1) is associated with a kyphosis corrector. Thekyphosis corrector must meet the positioning requirements for theorthosis. The kyphosis corrector treats analgesic attitudes or formingkyphosis.

It is composed of an inverted T of thermoformable plastic, moldedbetween omoplates and starting from the upper part of the T; twoinextensible tufted straps surrounding the armpit hollows. The device isfinished with an abdominal strap which could conceivably feature anarticulated anterior valve V that molds the rib cage vents in order toenhance its corrective capacity in the case of a kyphotic attitude thatis too underscored (FIG. 7, 8, 9, 10) or an analgesic or formingkyphoscoliosis.

In confirmed kyphosis, the thermo formable posterior valve will coverthe sub-acromial parts of the two omoplates, without going over the topof the kyphosis (FIG. 11, 12) on top and the anterior and posterioriliac spines below. The scar orthosis thus has an optimized action onthe anterior thoracic teguments.

A variation of the orthosis features concentric units but these units donot necessarily have the same center; one unit can cover one or severalothers; which allows treatment of large asymmetric heterogeneous scarsand to achieve progress in treatment.

The orthosis can be used over all or part of the body: face, canthi, earspeculum, trunk, perineum, limbs, hands, spaces between fingers andtoes, fingers, toes, feet and arches by adding units to soles.

The orthosis can be optimized during its design by tests, para-clinicalexaminations of scars (Doppler echo, Doppler laser to measure thicknessof residual derma), to be completed by CAD or CAM computer handlingwhich allows the shape, components and characteristics of the optimalvisco-elastic system to be determined. It incorporates the calculationof the deformation induced by movements within the usual degrees offreedom of the adjacent joints.

Orthoses (1) derived from the invention can be prefabricated for atopographic contour defined using statistical data, based on thefrequency of complications. They are less active than those made toorder, because they are not adapted to the great individual variabilityassociated with accidents, level of care, and individual contours. Unitsthat are less impressive in their performance can be made of plastic,foam, gel, silicone or any other material that includes a discharge areacutout or association of materials of different shore hardnesses. Asimple ring of silicone, a wavy elastic material under pressure by acompressive or banding garment that fulfills a small portion of thefunctions of the custom-made units. The associated activator is oftenrudimentary.

The action of the orthosis differs from the one that distributespressures, such as that offered by a good anti-eschar mattress. Besidesits preventive action, it has a therapeutic action that is oriented ontothe scar, zone by zone.

The action of orthosis (1) is to distinguish between the action of acompressive garment (36) (FIG. 6) which distributes a staggered variablepressure on the height of the limb segments, without the possibility ofmodulating the pressures on the scar at a given level. The interpositionof foam (37) (FIG. 6), silicone in a smooth plate traced onto the scarallows us, moreover, to increase and focus pressures in order to obtainan overall smooth scar, without variability in action or between-scarrestructuring effect.

The rigid pneumatic or hydraulic mask has an action that is comparableto related garments.

A simple unit (2) under the garment is more effective, and it bringsanother dimension, comprised of a new selectivity of areas subjected tocompression and acts beyond the scar contact surface. This can be thepolymerized silicone in the fiber, or glued to compressive garments thatare custom made commercially. A manufactured fabric containing, at thelevel of its scar surface, projections made of silicone or othermaterial would also be only partly effective. These are nothing butincomplete derivatives of the invention.

The introduction of orthoses is done gradually by day for safetyreasons. It is active starting from the third hour; beyond that, itsaction is proportional to the amount of time it is worn. This is veryuseful during introduction and during gradual weaning off the device.Progress requires that it be renewed during the 3^(rd) month; since thepriority scale of indications has progressed. Freedom of movement can beoffered to the patient several months earlier than with standardtreatment. The earliest improvement seen involves flexibility.Developmental stages are in general from 3 to 6 weeks.

According to one manner of embodiment, the orthosis is made of flexiblethermo formable plastic of a thickness from 1 to 4 mm. The depth of thegroove and the width designed for contact are from 0.1 to 15 mm. Thecupola measures between 0.2 and 25 cm in it largest diameter. In thepresence of adhesions, retraction or anchorages all units are consideredto be interactive.

1. A scarring orthosis comprising a plate in which reliefs are formed; the reliefs being sized and shaped to exert differential pressure on only a portion of a scar so as to control hypertrophy, retraction and fibrosis; the reliefs being molded in an elastic plate and comprising at least one curved groove shaped to act on certain selected regions of dermal scarring thickness and at least one cupola; said groove surrounding said cupola; wherein the groove has a bottom spaced from a first side of the plane of the plate and the cupola has a top spaced from a second, opposite side of the plane of the plate such that said groove and said cupola are on opposite sides of the plane of said plate, whereby said orthosis increases the elasticity in its deep plane and modulates the force exerted there, so that it can increase pressure locally on the back of the groove when it is pushed by a treatment unit.
 2. A scarring orthosis comprising a plate in which reliefs are formed; the reliefs being sized and shaped to exert differential pressure on only a portion of a scar so as to control hypertrophy, retraction and fibrosis; the reliefs being molded in an elastic plate and comprise curved grooves extending below one side of the plane of the plate and a cupola above the other side of the plane of the plate so that said grooves act on selected regions of dermal scarring thickness; said groove surrounding said cupola.
 3. The orthosis of claim 1 wherein the shape of the groove follows a curve determined according to the areas and the depth of the scar to be treated.
 4. A scarring orthosis comprising a plate formed of at least one differential pressure exerting relief sized and shaped to exert a varying pressure across only a portion of the scar so as to control hypertrophy; the at least one relief being molded in an elastic plate and comprising a curved dermal engaging groove defining a trough which extends below the plane of the plate and a cupola which extends above the plane of the plate so that the orthosis acts on selected regions of dermal scarring thickness; said groove surrounding said cupola; the plate being divided into several units, comprising one or more grooves that make a shape, in which at least two grooves are adapted to be arranged on the skin so as to have a coupled action that is sufficiently elastic to store and exert adequate pressure by the plate.
 5. The orthosis of claim 1 including an activator comprised of a cuff that is affixed to an edge of the groove, adjoining the cupola which allows the orthosis to be affixed to the patient, and comprising a means designed to locally increase pressure in the deep areas of the grooves; said means comprising associated elastic and rigid elements to create a counter support that allows concavities to be treated.
 6. The orthosis of claim 5 wherein the plate is divided into several units; the activator and units being made of the same material or different materials affixed to the edges of the units.
 7. The orthosis of claim 4 wherein the orthosis comprises a single unit or a plurality of units which act together as a system; said units being made of foam or gel or any other material.
 8. The orthosis of claim 4 wherein the activator and units are made of the same material or different materials affixed to edges of the units.
 9. The orthosis of claim 7 wherein the grooves in combination define a shape that is closed.
 10. The orthosis of claim 7 wherein the grooves in combination define a shape that is opened.
 11. The orthosis of claim 4 wherein the plate is formed from a material has an elasticity and/or hardness that is locally different.
 12. The orthosis of claim 11 wherein the material is a plastic, foam, gel, or silicone.
 13. The orthosis of claim 4 wherein the orthosis is in the shape of an insulated flexible mask used in addition to and under a rigid mask, or a rigid mask with removable separate units.
 14. The orthosis of claim 4 wherein the orthosis is associated with an original kyphoscoliosis corrector that treats analgesic attitudes.
 15. The orthosis of claim 4 wherein said units each comprise a simple ring of silicone, a wavy elastic material under pressure by a compressive or banding garment.
 16. The orthosis of claim 4 wherein each said unit comprises polymerized silicone in a fiber, or is glued to a compressive garment.
 17. The orthosis of claim 14 wherein the original kyphoscoliosis corrector is composed of an inverted T formed of thermoformable plastic, molded between omoblades and starting from an upper part of the T, two inextensible tufted straps adapted to surround armpit hollows and an abdominal strap.
 18. The orthosis of claim 17 wherein said straps include an articulated anterior valve that molds rib cage vents in order to enhance its corrective capacity in the case a kyphotic attitude that is too underscored or an analgesic or forming kyphoscoliosis.
 19. The orthosis of claim 18 wherein in confirmed kyphosis, a thermoformable posterior valve is adapted to cover the sub-acromial parts of the two omoblades, without ever going over the top of the kyphosis on top and the anterior and posterior iliac spines below, the scar orthosis having an optimized action on the anterior thoracic teguments.
 20. The orthosis of claim 7 wherein said units are comprised of an association of materials of different shore hardness values.
 21. The orthosis of claim 7 wherein said units slide or are glued under a compressive garment. 